Actively Recruiting
Control Network Neuromodulation to Enhance Cognitive Training in Complex Traumatic Brain Injury
Led by University of New Mexico · Updated on 2025-11-12
108
Participants Needed
5
Research Sites
218 weeks
Total Duration
On this page
Sponsors
U
University of New Mexico
Lead Sponsor
T
The Mind Research Network
Collaborating Sponsor
AI-Summary
What this Trial Is About
The CONNECT-TBI Trial aims to develop safe, effective treatments for complex mTBI that improve cognitive functioning. Based on the compelling preliminary data generated by our study team, the objective of this study is to conduct a randomized, double-blinded, sham-controlled Phase II clinical trial of APT-3 combined with rTMS, HD-tDCS, or sham to treat cognitive control deficits in Veterans with complex mTBI and PPCS. At the Baseline Visit, participants will undergo demographic, neuropsychological, behavioral, and quality of life testing. They will also undergo structural MRI to permit modeling of their brain, resting/task-related fMRI to identify the CCN, and pseudocontinuous arterial spin labeling (pCASL) and diffusion tensor imaging (DTI) to assess for other pathologies. They will then be randomized to 16 sessions of APT-3 with concurrent rTMS, HD-tDCS, or sham stimulation delivered to the unique functional left dorsolateral prefrontal cortex (DLPFC), a primary node of the CCN. Lastly, they will repeat all baseline tests, and report on 3- and 6-month recovery levels to establish longevity and stability of subjective benefit. Given that this individualization protocol has never been attempted for cognitive rehabilitation in military mTBI, we expect this trial will generate useful effect sizes for HD-tDCS and rTMS to be used for powering the next step, a Phase III multi-center trial.
CONDITIONS
Official Title
Control Network Neuromodulation to Enhance Cognitive Training in Complex Traumatic Brain Injury
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Veterans and Warfighters aged 18 to 59 years
- Mild traumatic brain injury with documented alteration in neurological function or loss of consciousness less than 30 minutes
- Injury occurred between 3 months and 5 years ago
- Less than 24 hours of post-traumatic amnesia
- Subjective post-TBI cognitive deficits with specified severity on the NSI cognitive symptoms scale
- Fluent in English
- Stable doses of any psychotropic medications for at least 2 months prior to enrollment
You will not qualify if you...
- History of neurological disease or seizures beyond immediate post-traumatic seizure
- History of psychosis
- Current or recent (within 2 years) substance or alcohol dependence
- Skull discontinuity or artificial craniotomy cover
- Implanted metal or electrical devices (e.g., pacemaker)
- Medical hospitalization within the past 3 weeks
- Conditions preventing protocol completion (e.g., significant agitation)
- Appointment of a legal representative or inability to consent
- Significant hearing loss or blindness that prevents cognitive training
- Ongoing litigation related to TBI
- Contraindications to MRI or exposure to strong magnetic fields such as severe claustrophobia
- Pregnancy
- Membership in vulnerable populations including minors, prisoners, or adults unable to consent
- Glasgow coma scale less than 13 or greater than 15 upon emergency admission if available
AI-Screening
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Trial Site Locations
Total: 5 locations
1
Minneapolis Veterans Affairs Medical Center
Minneapolis, Minnesota, United States, 55417
Actively Recruiting
2
The University of Minnesota
Minneapolis, Minnesota, United States, 55455
Active, Not Recruiting
3
The Mind Research Network
Albuquerque, New Mexico, United States, 87106
Active, Not Recruiting
4
The University of New Mexico
Albuquerque, New Mexico, United States, 87106
Active, Not Recruiting
5
New Mexico Veterans Affairs Health Care System
Albuquerque, New Mexico, United States, 87108
Actively Recruiting
Research Team
C
Cesar J Ojeda, MBA
CONTACT
D
Davin k Quinn, MD, FACLP
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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